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NCT04478123 · ADVERSE EVENTS

Adverse events

Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer · Source last updated 2024-02-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 42 days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Romiplostim

Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.

0 / 6262 / 627 / 62

Group identifiers: EG000: Romiplostim

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      Lymphocyte count decreased
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      Platelet count decreased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      White blood cell decreased
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        53
        num At Risk
        62
      term
      Neutrophil count decreased
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        40
        num At Risk
        62
      term
      Anemia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        62
      term
      Blood bilirubin increased
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        62
      term
      Hyponatremia
    Complete source fields
    event Groups
    1. deaths Num Affected
      7
      deaths Num At Risk
      62
      description
      Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
      id
      EG000
      other Num Affected
      62
      other Num At Risk
      62
      serious Num Affected
      0
      serious Num At Risk
      62
      title
      Romiplostim
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      Lymphocyte count decreased
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      Platelet count decreased
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        62
        num At Risk
        62
      term
      White blood cell decreased
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        53
        num At Risk
        62
      term
      Neutrophil count decreased
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        40
        num At Risk
        62
      term
      Anemia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        62
      term
      Blood bilirubin increased
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        62
      term
      Hyponatremia
    time Frame
    Up to 42 days

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice